FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELVI 675 DIGITRON
K Number: K843296
·
Decision Sep 13, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
9
Review Days
23
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Basic Information
- Device Name
- ELVI 675 DIGITRON
- K Number
- K843296
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Logos Scientific, Inc.
- Date Received
- August 21, 1984
- Decision Date
- September 13, 1984
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Logos Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Nov 8, 1990 | Substantially Equivalent |
| K843375 | ELVI 655 FLAME PHOTOMETER | May 20, 1985 | Substantially Equivalent |
| K844710 | EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD | Jan 7, 1985 | Substantially Equivalent |
| K842313 | ELVI 146 SEROSCAN | Sep 10, 1984 | Substantially Equivalent |
| K842056 | ELVI 165 PROTEO SEROSKOP | Jun 22, 1984 | Substantially Equivalent |
| K841804 | ELVI 70 SAFETY CHAMBER | May 31, 1984 | Substantially Equivalent |
| K840757 | ELVI 444 BILITRON | May 30, 1984 | Substantially Equivalent |
| K841288 | ELVI 18 | May 2, 1984 | Substantially Equivalent |